TUKOL MAX ACTION SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution

Tukol Max Action Severe Congestion and Cough by

Drug Labeling and Warnings

Tukol Max Action Severe Congestion and Cough by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold
• cough due to minor throat and bronchial irritation
• nasal congestion

Warnings

Do not use

• for children under 12 years of age
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Do not take more than 6 doses in any 24 hour period
• Use dose cup provided

• age: dose
• adults and children 12 years and older: 20 mL every 4 hours
• children under 12 years of age: do not use

Other information

• Each 20 mL dose contains : sodium 14 mg
• Store at 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue#1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or comments?

1 877 99 GENOM (43666)

Monday to Friday from 8 AM to 6 PM, Central time.

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77027

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HCl

Tukol®

MAX ACTION

Severe CONGESTION & COUGH

• Clears Nasal & Chest Congestion
• Thins & Loosens Mucus
• Controls Cough

Ages 12+     6 FL OZ (177 ml)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)Carton

MAX STRENGTH

DEXTROMETHORPHAN HBR / GUAIFENESIN / PHENYLEPHRINE HCl

Tukol®

MAX ACTION

Severe
CONGESTION & COUGH

• Clears Nasal & Chest Congestion
• Thins & Loosens Mucus
• Controls Cough

Ages 12+     6 FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-917
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PINEAPPLE (UNII: 2A88ZO081O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-917-18	1 in 1 CARTON	11/15/2017
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/15/2017

Labeler - Genomma Lab USA Inc (832323534)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(50066-917)